Bureaucratic Shakeup and More Layoffs at Merck?

Posted in BioBusiness

The Twitterverse was buzzing with activity late last week about a possible shakeup at Merck as Roger Perlmutter takes control as its new head of R&D.  As many of you may know, Perlmutter used to work at Merck but left to become Amgen’s Executive VP of R&D when Peter Kim, the now former Head of Merck’s R&D, was hired several years

Kim’s tenure at Merck was rife with missteps, misdirection and drug approval failures. So, when Amgen replaced its CEO and Merck fired Kim, Perlmutter saw an opportunity to return to the fold with Merck now under the tutelage of CEO Ken Frazier (the man who engineered the company’s Vioxx legal strategy).

Fierce Biotech substantiated the Twitter rumors that a major shakeup may be underway at Merck. According to an article published early on Friday, a Merck spokesperson confirmed that Perlmutter is indeed shaking things up and reorganizing Merck’s R&D infrastructure.

The spokesperson said

“I can confirm that some members of management, but not all Franchise leadership, are leaving the company but are working to ensure a smooth transition.”

The departure of several senior leaders was later confirmed by the Wall Street Journal.  While not confirmed, rumors suggested that Rupert Vessey will lead Merck’s Discovery and Early Development programs.

While Merck spends close to $8 billion annually on R&D, its late stage development pipeline is thin and Perlmutter was hired to strengthen it. Changes at the top usually mean that other changes will take place among the rank and file. That said, stay tuned for possible additional layoffs among Merck R&D personnel.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

Sandoz Moves Its Biosimilar Development Strategy Forward

Posted in BioEducation

Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz’s biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!!!!

 

The Amgen Chronicles

Posted in BioBusiness

I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status

For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO. 

EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success.  The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.

The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.

In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.

Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.

Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.

The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Amgen Hires Tony Hooper and Lays off Nearly 400 Employees

Posted in BioJobBuzz

Last week Amgen announced that it was reorganizing its R&D structure and that layoffs were likely. Today, the company announced that it had hired Tony Hooper, very recently the former senior vice president, Commercial Operations, and president, U.S., Japan and Intercontinental at Bristol Myers Squibb (BMS) to overhaul commercial operations. Shortly after the Hooper announcement almost 400 Amgen employees learned that they would lose their jobs.

Hooper will replace Jim Daly as executive vice president of commercial operations at Amgen. During his 16 year tenure at BMS, Hooper ran commercial operations for all of BMS’ products in both mature and emerging markets.

Amgen is reorganizing its R&D efforts because its EPO franchise revenues are declining and it is preparing to launch its recently approved osteoporosis drug called Prolia. According to a post on today’s Pharmalot blog the R&D overhaul is not an across the board reduction but will affect multiple sites. At present, Amgen employs about 17,600 workers worldwide.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

 

Big Changes In Store For Amgen Employees?

Posted in BioJobBuzz

Remember when Amgen was the world’s largest and most profitable biotechnology company? That was way back in 2006 before its marketing and sales team got in trouble for “pushing” the sale of its erythropoietin (EPO) product Epogen and Aranesp beyond acceptable patient safety limits. This, along with a relatively thin new drug pipeline, has for the past five years or so relegated the company to second tier biotech company status.

To make matter worse, a company spokesperson mentioned its third-quarter earnings conference call today that the company is

 “…currently evaluating some changes within our Research & Development organization to improve focus and to reallocate resources to key pipeline assets and activities." This typically means that the possibility of layoffs is real. The last major restructuring of the company took place in 2007 and it resulted in the elimination of more than 2,000 jobs worldwide, including about 700 in Thousand Oaks.

This past June, Amgen announced plans to eliminate 134 jobs at two of its manufacturing sites in Colorado.

The company employs about 17,000 people, including about 6,200 in Thousand Oaks. Amgen also has research and development facilities in Thousand Oaks, South San Francisco,; Cambridge and Woburn, Mass.; Seattle; Burnaby, British Columbia, Canada; Abingdon, Cambridge and Uxbridge, Great Britain; and Regensburg, Germany.

In 2010, Amgen’s revenue totaled $15.1 billion, while research and development cost $2.9 billion, according to the company. Its net profit last year totaled $4.63 billion, up slightly less than 1 percent from 2009.

Could this signal the beginning of the end of this once formidable biotechnology giant? If I was an Amgen employee I would be feverishly updating my CV right about now!

Until next time…

Good Luck and Good Job Hunting!!

 

Bayer CEO: "Make Me An Offer!"

Posted in BioBusiness

Bloomberg news today reported that Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

While Dekkers did not name the companies that he considers to be Bayer’s “equals”, convention wisdom suggests the list is likely to include Eli Lilly & Co, Bristol Myers Squibb (BMS) and Amgen, one of the last remaining, large, independent biotechnology companies. Lilly and BMS both  had  sales revenue similar to Bayer’s last year whereas Amgen had lower sales of $15.1 billion. 

The reasons for a potential merger are not entirely clear. However, Bayer Healthcare is waiting to hear about regulatory approval of its new anticoagulant Xarelto medicine for irregular heartbeat patients who face the risk of a stroke. Analysts predict that Xarelto may exceed $2.5 billion in global sales. Approval of Xarelto will change Bayer’s valuation and consequently, don’t expect merger talks to begin until after FDA renders its decision on the drug.

Meanwhile, Bayer’s top-selling multiple sclerosis (MS) treatment betaseron faces competition from a similar Novartis drug called Extavia, and from its new oral MS medication Gilenya. Sales of betaseron fell 5 percent in the first quarter. Moreover, sales of Bayer’s birth-control pill Yaz dropped 18 percent after Teva Pharmaceutical Industries Ltd. introduced a generic version of the medicine.

Lilly, BMS and Amgen all face significant challenges in the future and both BMS and Amgen have been repeatedly mentioned as takeover targets. However, from a historical perspective mergers of mediocre or struggling companies rarely yield stronger, more financially robust ones! But, what do I know, I am just a scientist!

Stayed tuned for more updates.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Is Latin American The Next Big Market?

Posted in BioBusiness

While India and China have been getting much of the attention and press over the past few years, Latin America is quietly become a market to watch for the life sciences industry.  According to industry analysts,the Brazilian pharmaceutical market has been growing at a rate of about 12 percent per year and is expected to be the world’s fifth-largest pharmaceutical market by 2015.

A number of companies have been doing deal in Latin America mainly in Mexico and Brazil. Late last week, Amgen announced that it had purchased the privately-held Brazilian company Bergamo for about $215 million. As part of the transaction Amgen had reacquired marketing rights in the country to several Amgen products. Also, Amgen also agreed with Hypermarcas, a maker of personal hygiene products, to reacquire Brazilian rights to several products, including its Vectibix cancer drug.

Bergamo, which had $80 million in revenue last year, supplies medicines to the Brazilian hospital sector and has capabilities in oncology. Amgen, which is acting more and more like a pharmaceutical company rather than a biotechnology company, has clearly signaled its intention to take advantage of opportunities in emerging markets in BRIC (Brazil, China, India and China) counties.

Amgen has been struggling of late and its drug development pipeline, like many of its pharmaceutical rivals, has grown thin over the past decade.  Don’t be surprised if Amgen is the next biotechnology company to be purchased by a big pharma company.  Merck’s intention to enter into the biosimilar and biomanufacturing sectors suggest that Merck may be a likely suitor to gain control of the EPO and Neupogen franchises as well as Amgen’s stake in the Enbrel market.

Until next time…

Good Luck and Good Job Hunting (try Brazil)

 

What Ever Happened to Amgen?

Posted in BioBusiness

Five years ago Amgen was the world’s largest biotechnology and was, by many accounts, the darling of Wall Street. But, today, there is little mention of the once formidable biotechnology company that many startups attempted to emulate. Like other companies, Amgen ran into pipeline problems, medical issues with existing blockbuster drugs (remember the whole hematocrit brouhaha over Epogen and Aranesp its flagship anemia products), lower drug sales and ultimately the perception that the company had lost its innovative edge. However, it now appears that Amgen is making something of a comeback and may have been quietly preparing itself for its  “rebirth” over the past few years.

According to an article in today’s NY Times, Amgen agreed to purchase BioVex, a closely held oncology company for $425 million and as much as $575 million in milestone payments. BioVex’s lead product, an experimental cancer vaccine Oncovex, is in late stage clinical development. It was developed to treat metastatic melanoma. Oncovex is also being evaluated for head and neck cancer.  Over the past five years, Amgen has acquired seven companies (with an average deal value of about $264 million) in oncology and other therapeutic areas indicating a willingness to create new drugs to treat diseases rather than symptoms commonly associated with them.

In other news, the company announced that it was raising it price for some of its largest selling drugs including Aranesp, Neupogen and Neulasta. Another sign that the once mighty company may be trying to get back into the game and compete with archrival Genentech (now a subsidiary of Roche) for the title of the world’s largest biotechnology company.

Until next time…

Good Luck and Good Job Hunting!!!!!!.

 

The Convergence of Pharma Celebrity Spokespersons and Web 2.0

Posted in Social Media

Over the past few months, a number of celebrities have agreed to help pharmaceutical and biotechnology companies pitch their products in direct-to-consumer advertising campaigns. Perhaps this is related to the economic downturn and these actors are having trouble finding high paying gigs to support their lifestyles. Alternatively, their motives may be altruistic or they or one of their loved ones may suffer from a life-altering or threatening illness.

The latest addition to the celebrity pitchperson parade is the soap opera diva Susan Lucci. After her husband Helmut Huber was unexpectedly diagnosed a decade ago with atrial fibrillation—a type of irregular heartbeat that increase the risk of stroke five-fold, Lucci yesterday announced that she and her husband would partner with Boehringer Ingelheim the National Stroke Association and StopAfib.org to launch a new education campaign to raise awareness of atrial fibrillation. Financial terms of the relationship were not disclosed.

In other news, Amgen and Pfizer yesterday announced the joint launch of "Psophisticated Style:  A Guide to Everyday Style and Psoriasis™," an online resource, providing a wealth of style advice specifically for people with psoriasis.

The new online presence will be hosted by B-list celebrity Tim Gunn, mentor to the designers on TV’s "Project Runway" and chief creative officer of Liz Claiborne, Inc. and dermatologist Susan C. Taylor, M.D., the style guide includes five videos, which illustrate various style issues for individuals with psoriasis. Practical and insightful highlights from each video are also available and can be printed.  The new website is well designed and has a decidedly web 2.0 look and feel to it. And, you can even follow Psophisticated Style on Facebook and share the site with your friends!

According to a press release Addressing Psoriasis™ was developed to inspire people with plaque psoriasis to actively manage their condition, be more confident and not allow the condition to inhibit their everyday style. 

Despite the slow uptake, Pharma’s attitude on the use of social media is beginning to shift. Last week, Eli Lilly &Co announced the launch of Lilly Pad a blog and twitter feed designed to provide information and helpful tips to patients with diabetes. Yesterday at the Business Development Institute’s HealthCare Social Communications Leadership Forum in Manhattan, Todd Siesky , Public Relations Manager, Roche Diabetes Care described an innovative and creative initiative (started two years ago) to establish a network of influential bloggers in the diabetes space. The bloggers are not paid and do not benefit financially from their interactions with the company. Roche interacts with the blogging network on a quarterly basis and has held two summits to bring the bloggers together to brainstorm and interact with one another (Roche covers airfare and hotel accommodations).

Also, Ted Phelan, Senior Regional Scientific Manager Medical Affairs at Astra Zeneca gave an illuminating talk about his company’s efforts to build a physician community in the gastrointestinal therapeutic space. Ted’s take away from his impromptu presentation (the originally scheduled Astra Zeneca representative couldn’t attend) was you won’t be successful unless you understand the needs of community members (he is married to a physician).

For those of you who may not closely follow the pharmaceutical social media space, building Facebook fan pages and creating a Twitter feed are no longer de rigueur. Instead, the next big thing is building company-sponsored, unbranded, online patient and physician communities around different therapeutic indications! Move over Patients Like Me, there may be some new kids on the block in the very near future!

Until next time…

Good Luck and Good Tweeting!!!!!

 

Goodbye "DNA"

Posted in BioJobBuzz

It’s official!  Roche has secured more than 96 percent of shares in Genentech Inc, completing its $46.8 billion buyout of the U.S. biotech group. It now holds some 93 percent of outstanding Genentech shares, a further 3 percent are guaranteed to be delivered within the next three business days and it will integrate the U.S. biotech group as soon as possible.

Soon after Roche completed the transaction on Thursday, the company announced that Genentech’s common stock would no longer be traded on the New York Stock Exchange.

Genentech, founded in 1976, was one of the first and most successful biotechnology companies in the US. After lagging behind rival Amgen for most of the 1990s, Genentech eclipsed Amgen in the early 2000s on the strength of its oncology franchise (Herceptin and Avastin) and its deep drug development pipeline.

Its acquisition by Roche truly signals the end of an era in history of the American biotechnology industry.

Until next time…

Good Luck and Good Cloning! 

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